BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY

    MDR report key: 2831646 · Received November 9, 2012

    Report

    Report Number
    9681121-2012-00035
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 17, 2012
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVAL. THE MFG REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MFG PROCESS. NO COMPLAINT OR MFG TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FROM AN EYE CARE PROFESSIONAL THAT A (B)(6) GIRL DEVELOPED A CORNEAL ULCER IN THE RIGHT EYE THAT WAS NOT HEALED. ADDITIONAL INFO RECEIVED FROM THE EYE CARE PROFESSIONAL INDICATES THE PT WAS DIAGNOSED WITH A CENTRAL CORNEAL ULCER, 2 MILLIMETERS IN SIZE, IN THE RIGHT EYE. AN UNSPECIFIED DROP WAS PRESCRIBED AND LENS WEAR WAS TEMPORARILY DISCONTINUED. THE ISSUE RESOLVED. NO SCARRING WAS OBSERVED AND LENS WEAR RESUMED WITHOUT FURTHER ISSUES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX NIGHT & DAY LENSES, SOFT CONTACTS, EXTENDED WEAR LPM PT CIBA VISION BATAM

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention